UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022296
Receipt number R000025603
Scientific Title Evaluation of regulatory T cell and disease activity after transdermal administration of Dovonex(r) ointment 50ug/g in patients with rheumatoid arthritis
Date of disclosure of the study information 2016/05/15
Last modified on 2016/09/01 09:28:32

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Basic information

Public title

Evaluation of regulatory T cell and disease activity after transdermal administration of Dovonex(r) ointment 50ug/g in patients with rheumatoid arthritis

Acronym

Evaluation of regulatory T cell and disease activity after transdermal administration of Dovonex(r) ointment 50ug/g in patients with rheumatoid arthritis

Scientific Title

Evaluation of regulatory T cell and disease activity after transdermal administration of Dovonex(r) ointment 50ug/g in patients with rheumatoid arthritis

Scientific Title:Acronym

Evaluation of regulatory T cell and disease activity after transdermal administration of Dovonex(r) ointment 50ug/g in patients with rheumatoid arthritis

Region

Japan


Condition

Condition

Rheumatoid arthritis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate effect on Treg and change in disease activity after transdermal administration of Dovonex(r) ointment 50ug/g in patients with rheumatoid arthritis

Basic objectives2

Pharmacodynamics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The change of Treg are evaluated before and 8 days after transermal administration of Dovonex(r) ointment 50ug/g.

Key secondary outcomes

Evaluate change in disease activity using RA activity indexes


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Transdermal administration of 5g of Dovonex(r) ointment 50ug/g twice daily for 7 days. 7 days administration and following 7 days wash-out period are repeated twice.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1, Patients with rheumatoid arthritis diagnosed based on either ACR 1987 revised criteria or 2010 ACR/EULAR Classification
Criteria for Rheumatoid Arthritis.
2, Patients currently treated with antirheumatic drug (except for Cyclosporine and Tacrolimus)
3, 20 years of age or older at the time of consent.
4, Patients who are not during pregnancy or lactation.
5, Patients who consented in writing prior to the commencement of the study procedure.

Key exclusion criteria

1, Patients with other systemic autoimmune disease (e.g. systemic erythematosus).
2, Patients with history of hypersensitivity to Calcipotriol.
3, Patients with or with the risk of hypercalcemia, or whose serum calcium level exceed normal range.
4, Patients currently treated with Calcineurin antagonist (Cyclosporine or Tacrolimus).
5, Patients currently treated with anti-osteoporosis drugs (Vitamin D3, PTH).
6, Patients whose eGFR is 60 or lower.
7, Patients treated for bacterial infection within 30 days prior to the first administration of the study drug.
8, Uncooperative patients who might not comply with the protocol procedure.
9, Patients with malignant tumor requiring treatment within past 5 years.
10, Patients judged inappropriate for this study by principal investigator.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name TOMOMI TSURU

Organization

Medical CO.LTA PS Clinic

Division name

Director

Zip code


Address

6-18, TENYAMACHI, HAKATA-KU, FUKUOKA, FUKUOKA

TEL

0922837777

Email

tomomi-tsuru@lta-med.com


Public contact

Name of contact person

1st name
Middle name
Last name MIDORI SUZAKI

Organization

Medical Co.LTA PS Clinic

Division name

Nurse

Zip code


Address

6-18, TENYAMACHI, HAKATA-KU, FUKUOKA, FUKUOKA

TEL

0922837777

Homepage URL


Email

midori-suzaki@lta-med.com


Sponsor or person

Institute

Medical Co.LTA PS Clinic

Institute

Department

Personal name



Funding Source

Organization

Qmune

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Medical Co.LTA PS Clinic

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

医療法人相生会ピーエスクリニック(福岡県)


Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2016 Year 04 Month 25 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 30 Day

Last follow-up date

2016 Year 09 Month 30 Day

Date of closure to data entry

2016 Year 10 Month 30 Day

Date trial data considered complete

2016 Year 12 Month 31 Day

Date analysis concluded

2017 Year 04 Month 30 Day


Other

Other related information



Management information

Registered date

2016 Year 05 Month 12 Day

Last modified on

2016 Year 09 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025603


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name